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DNA Methyltransferase Inhibitor
Decitabine for Myelodysplastic Syndrome
Phase 2
Waitlist Available
Led By Armin Rashidi, MD, PhD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is for a new treatment of relapsed AML or MDS following a stem cell transplant. Up to 4 cycles of treatment will be given, depending on how the patient responds and how well they tolerate the treatment.
Eligible Conditions
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Best Response
Complete Remission (CR)
Efficacy of Combined Modality Treatment (Ruxolitinib, Decitabine, and DLI) for Relapsed AML or MDS Post Allo-HCT: Rate of Overall Survival (OS)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Decitabine + Ruxolitinib + DLIExperimental Treatment3 Interventions
Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Ruxolitinib
2018
Completed Phase 3
~1140
Donor Lymphocyte Infusion (DLI)
2014
Completed Phase 3
~190
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Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,611 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,151 Total Patients Enrolled
Armin Rashidi, MD, PhDPrincipal InvestigatorDivision of Hematology, Oncology and Transplantation, University of Minnesota
6 Previous Clinical Trials
182 Total Patients Enrolled
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